Last Updated on April 28, 2025
The following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to pharmaceutical products.
1. Drug Manufacturing License
Guidance on Establishment of Pharmaceutical Unit and Post License Changes
English (2nd Edition) (Effective Date: 01 Nov 2024)
2. Drug Registration
Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
English ( 444 KB – PDF)
Guidance on Preparation of Summary of Product Characteristics (SmPC)
English ( 386 KB – PDF)
Guideline on Registration requirements to establish the interchangeability of Pharmaceutical Drug Products
English ( 620 KB – PDF)
Guidance on Labelling and Packing of Drugs
English ( 381 KB – PDF)
Guidance on Patient Information Leaflet (PIL)
English ( 363 KB – PDF)
Guidelines on Good Review Practices
English ( 551 KB – PDF)
Frequently asked questions about Form 5F (Common Technical Documents)
English ( 256 KB – PDF)
3. Post Approval Variations of Drugs
Post Registration Variation Guidelines For Pharmaceutical and Biological Products
English ( 735 KB – PDF)
4. Non Routine Registration pathways for Drug Registration
Priority Review and Accelerated Approval of Registration / Market Authorization
English ( 302 KB – PDF)
5. Reliance Mechanism
Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)
6. Appeals Against Regulatory Decisions
Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)